Suggested remit: To appraise the clinical and cost effectiveness of donanemab within its marketing authorisation for treating mild cognitive impairment or mild dementia caused by Alzheimer’s disease.
- Status:
- In progress
- Technology type:
- Medicine
- Decision:
- Selected
- Reason for decision:
- Anticipate the topic will be of importance to patients, carers, professionals, commissioners and the health of the public to ensure clinical benefit is realised, inequalities in use addressed, and help them make the best use of NHS resources
- Process:
- STA Standard
- ID number:
- 6222
Provisional Schedule
- Appeal:
- 22 October 2025
Project Team
- Project lead
- Kate Moore
Email enquiries
If you have any queries please email [email protected]
- External Assessment Group:
- Southampton Health Technology Assessment Centre (SHTAC), University of Southampton
Stakeholders
- Companies sponsors
- Eli Lilly and Company (donanemab)
- Others
- Department of Health and Social Care
- NHS England
- UCL Dementia Research Centre
- Patient carer groups
- Alzheimer’s Research UK
- Alzheimer's Society
- Dementia UK
- Professional groups
- Association of British Neurologists
- British Nuclear Medicine Society
- College of Mental Health Pharmacy
- Faculty of Public Health
- Royal College of Physicians
- Royal College of Psychiatrists
- Royal College of Radiologists
- UK Clinical Pharmacy Association
- Associated public health groups
- None
- Comparator companies
- Eisai (donepezil) (confidentiality agreement signed, participating)
- Accord Healthcare (donepezil, memantine) (confidentiality agreement not signed, not participating)
- Accord-UK (donepezil, galantamine, memantine) (confidentiality agreement not signed, not participating)
- Aspire Pharma (galantamine) (confidentiality agreement not signed, not participating)
- Aurobindo Pharma – Milpharm (donepezil, galantamine) (confidentiality agreement not signed, not participating)
- Cipla (donepezil) (confidentiality agreement not signed, not participating)
- Dr Reddy’s Laboratories (galantamine, memantine, rivastigmine) (confidentiality agreement not signed, not participating)
- Fontus Health (galantamine) (confidentiality agreement not signed, not participating)
- Genus Pharmaceuticals (memantine) (confidentiality agreement not signed, not participating)
- Glenmark Pharmaceuticals (memantine) (confidentiality agreement not signed, not participating)
- Kent Pharma (rivastigmine) (confidentiality agreement not signed, not participating)
- Krka UK (memantine, rivastigmine) (confidentiality agreement not signed, not participating)
- Lundbeck (memantine) (confidentiality agreement not signed, not participating)
- Lupin Healthcare (memantine) (confidentiality agreement not signed, not participating)
- Mylan (donepezil, memantine, rivastigmine) (confidentiality agreement not signed, not participating)
- Novartis Pharmaceuticals (rivastigmine) (confidentiality agreement not signed, not participating)
- Ranbaxy, a Sun Pharmaceutical Company (donepezil) (confidentiality agreement not signed, not participating)
- Rosemont Pharmaceuticals (donepezil, memantine, rivastigmine) (confidentiality agreement not signed, not participating)
- Sandoz (galantamine, rivastigmine) (confidentiality agreement not signed, not participating)
- Takeda (galantamine) (confidentiality agreement not signed, not participating)
- Thame Laboratories (galantamine) (confidentiality agreement not signed, not participating)
- Zentiva (memantine, galantamine) (confidentiality agreement not signed, not participating
- General commentators
- All Wales Therapeutics and Toxicology Centre
- British National Formulary
- Department of Health, Social Services and Public Safety for Northern Ireland
- Healthcare Improvement Scotland
- Medicines and Healthcare products Regulatory Agency
- NHS Wales Joint Commissioning Committee
- Scottish Medicines Consortium
- Welsh Government
- Relevant research groups
- Cambridge Public Health
- National Institute for Health Research
- Research Institute for the Care of Older People
Timeline
Key events during the development of the guidance:
| Date | Update |
|---|---|
| 19 June 2025 - 03 July 2025 | Final draft guidance |
| 14 May 2025 | Committee meeting: 3 |
| 06 March 2025 - 27 March 2025 | Draft guidance: 2 |
| 06 March 2025 | Following discussions with the company, NICE has agreed to hold a second draft guidance consultation and return for a third committee discussion to consider additional data. |
| 15 January 2025 | Committee meeting: 2 |
| 15 January 2025 | Declaration of interests |
| 23 October 2024 - 20 November 2024 | Draft guidance |
| 10 July 2024 | Following the update about licensing on 11 June, the anticipated publication date for this appraisal has been changed to TBC and will be updated once there is more clarity about when the licence is expected. |
| 03 July 2024 | Committee meeting: 1 (private meeting) |
| 11 June 2024 | The appraisal committee meeting for donanemab for treating mild cognitive impairment or mild dementia caused by Alzheimer’s disease, will go ahead on 3 July 2024 as previously advised. However, this will need to be a private meeting of the committee, without public observers. The reason the meeting needs to be in private is that we have received an update that the licence from the MHRA may not be granted by 3 July. NICE’s technology appraisal committees can only make recommendations on medicines licensed by the MHRA. So, it would not be appropriate for NICE to discuss the donanemab data in public or release any recommendations that pre-empt the MHRA decision. |
| 21 November 2023 | Invitation to participate |
| 07 August 2023 | Please note that at the request of the company, the timelines for this appraisal have been revised to allow them to develop a robust and comprehensive submission; the appraisal is now anticipated to begin in late November 2023. |
| 01 June 2023 - 29 June 2023 | Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators: 6222 |
| 31 March 2023 | In progress. DHSC referral received |
| 12 December 2022 | Awaiting development. Status change linked to Topic Selection Decision being set to Selected |
For further information on our processes and methods, please see our CHTE processes and methods manual